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Horizon 55 Bi-Con

by Westcon Contact Lens Co., Inc.

510(k) K945365

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945365 Date28 Dec 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HORIZON 55 BI-CON is a hydrophilic toric multifocal contact lens designed to correct astigmatism and presbyopia. It is a custom-made lens available in a wider parameter range than conventional lenses, providing options for unique prescriptions.

This device is supplied as a single-use, sterile lens and is intended for monthly replacement. It is not MRI safe and should be stored in a cool, dry place. The device is regulated under FDA 510(k) clearance (K945365) and is classified as a Class II medical device.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HORIZON 55 BI-CON contact lens used for?

    The HORIZON 55 BI-CON is a hydrophilic toric multifocal contact lens designed to correct astigmatism and presbyopia. It is a custom-made lens available in a wider parameter range than conventional lenses, providing options for unique prescriptions.

  • How is the HORIZON 55 BI-CON lens supplied?

    The HORIZON 55 BI-CON is supplied as a single-use, sterile lens intended for monthly replacement.

  • What are the storage requirements for the HORIZON 55 BI-CON?

    The HORIZON 55 BI-CON should be stored in a cool, dry place.

  • Is the HORIZON 55 BI-CON safe for use in an MRI machine?

    No, the HORIZON 55 BI-CON is not MRI safe.